EFSA Neonicotinoid Statement: Unfit for Government Use

February 12, 2013

The European Food Safety Authority (EFSA) recently made news around the world with a Press Release that implied, without actually stating, that use of three neonicotinoid insecticides were harmful to bees.1

It is important to note that the EFSA Press Release hedged its views by noting that:

  • “In some cases EFSA was unable to finalise the assessments due to shortcomings in the available data;” and

  • “there is a high level of uncertainty in the latest evaluations.”

Not surprisingly, and in keeping with federal law and common sense, the US Environmental Protection Agency (EPA) has rebuffed calls to suspend use of the pesticides discussed by EFTA.2

The information supporting federal regulatory actions is governed by the Data Quality Act (DQA).3   The DQA, one of several governors of the regulatory state,4 sets standards for the quality of virtually all data disseminated by Executive Branch agencies.5

Agencies are not permitted to disseminate data until it passes through a pre-dissemination quality review process to assure its objectivity, utility and integrity.  Similarly, agencies may not use or rely on third-party data in their information disseminations unless the third-party data meets federal data quality standards.

In event that an agency does disseminate non-compliant data, the law gives affected persons the right to “seek and obtain” correction of the data.  The quality requirements and correction process apply to all data disseminated by agencies, even if it originated with prestigious international organizations.6a and 6b

As evidenced by the EFSA statement’s acknowledgment of the shortcomings of the EFSA data and the high level of uncertainty in their evaluations, the data discussed in the Press Release clearly does not meet US data quality requirements and cannot be used or relied on by federal agencies.  Moreover, under the DQA, federal agencies are required to consider the totality of available information.

One of the DQA’s requirements is Objectivity.  The White House Office of Management and Budget’s government-wide guidelines that are binding on all agencies explain that Objectivity “includes whether disseminated information is being presented in an accurate, clear, complete, and unbiased manner.”7

There is much information, often contradictory to the anti-neonicotinoid policies suggested by EFSA’s work, that US regulatory authorities would need to evaluate in considering any potential pesticide policy changes.

A few examples of recent research and findings which would need to be considered in a review of neonicotinoids and bee health include:

  • A study by Britain’s Food and Environment Agency and the University of Exeter which found that thiamethoxam, one of the neonicotinoids discussed by EFSA, was not responsible for causing colonies to collapse.

A newly released study from Britain’s Food and Environment Agency with the University of Exeter shoots down the claim that Syngenta’s neonicotinoid pesticide is the cause of Colony Collapse Disorder among the world’s honeybee populations. The new study admitted that pesticides can be harmful to individual bees, but it is unlikely to cause whole colonies to collapse.

“We do not yet have definitive evidence of the impact of these insecticides on honeybees and we should not be making any decisions on changes to policy on their use,” said James Cresswell, the exotoxicologist of the British study.8

  • Research at Yale University suggesting that it is antibiotics that are responsible for the decline in bee health.

The gut bacteria of honey bees have acquired several genes that confer resistance to tetracycline, a direct result of more than five decades of use of antibiotics by American beekeepers and a potential health hazard for bee colonies, a new study by Yale University researchers show.

The genetic analysis of the gut bacteria, which are believed to help in bees’ digestion and ability to ward off parasites, suggests changing antibiotic use by beekeepers might be one factor in the mysterious colony collapse disorder afflicting bee populations.

“No one pathogen or parasite is responsible for the mass die-offs, and many factors seem to be involved,” said Nancy Moran, senior author of the paper and the William H. Fleming, M.D. ’57 Professor of Ecology and Evolutionary Biology at Yale and the Microbial Diversity Institute at West Campus. “But it is interesting that major problems with these colonies began at the same time as the introduction of a new antibiotic in 2006.”9

  • A statement by the US EPA, after evaluating a formal request to take action against one of the one of the neonicotinoids discussed by EFSA:

After considering the petition and the supporting information, the EPA is denying the request to suspend clothianidin use because the petition fails to show that an imminent hazard to bees exists.  Under the FIFRA standard, suspension is appropriate only if there exists a substantial likelihood of serious, imminent harm. Having reviewed the petition and supporting information, the EPA does not believe there is a substantial likelihood of imminent serious harm from the use of clothianidin. Specifically, the EPA does not believe the petition demonstrates that the use of clothianidin is causing or will cause:

    • significant reduction in populations of domestic bees or native pollinators,

    • significant decreases in honey production,

    • serious effects on other agricultural systems as a result of decreases in pollination services or

    • a reduction in pollination of wild plants in a way that may alter ecosystems.10 [Emphasis added]

The above brief summary of a few of the recent science developments demonstrates that the new EFSA statements have no relevance to US regulatory decisions. Moreover, it clear that EFSA’s recent dissemination should not have any relevance to European regulatory decisions.

1. http://www.efsa.europa.eu/en/press/news/130116.htm

2. http://www.thecre.com/oira_pd/?p=3161

3. http://thecre.com/post

4. http://www.thecre.com/pdf/20110530_Governors_of_the_Regulatory_State.pdf

5. http://thecre.com/quality/index.html

6a., b.   See, http://www.thecre.com/pdf/20030908_correction.pdf and http://www.commercialalert.org/bushadmincomment.pdf

7.  http://www.whitehouse.gov/sites/default/files/omb/assets/omb/fedreg/reproducible2.pdf

8. Colleen Scherer, Ag Professional, “Syngenta pesticide does not collapse bee colonies,” available at, http://www.thecre.com/oira_pd/?p=281

9.  Yale News, available at http://www.thecre.com/oira_pd/?p=522

10. US EPA, “Pesticide News Story: The EPA Denies Petition Seeking Emergency Suspension of Clothianidin and Releases Petition for Public Review, available at http://www.epa.gov/oppfead1/cb/csb_page/updates/2012/clothianidin.html

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